A Study of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 9MW3011 in Patients With Polycythemia Vera

Korábbi kezelés

• Heart failure, unstable angina pectoris, myocardial infarction, and other thrombotic diseases within the 6 months prior to screening.
• Uncontrolled hypertension prior to screening.
• Blast cells and blast granulocytes in the peripheral blood within the 3 months prior to screening.
• Subjects who have used monoclonal antibodies within the 6 months prior to screening.
• Patients who have received vaccinations within 6 weeks prior to screening.
• Subjects who have received other antitumor therapeutic drugs for PV prior to screening.
• Chronic diseases requiring treatment with systemic glucocorticoids or other immunosuppressants.
• History of drug abuse or illicit drug use within 3 months prior to screening.
• Participation in other clinical trials within 3 months prior to screening.
• Planned elective surgery during the study.
• History of surgery within 3 months prior to screening.
• Intolerable iron deficiency-related symptoms judged by the investigator prior to the first dosing.

Más betegség

• Known positive for active hepatitis B, hepatitis C, syphilis or human immunodeficiency virus (HIV) infection.
• History of invasive malignancies within the last 5 years.
• Severe infection or uncontrolled active infection.
• Other hematological and lymphatic system diseases or any diseases causing hemolysis or erythrocyte instability.
• Other systemic diseases or a family history of systemic diseases, may affect the subject's safety or any other diseases and physiological conditions that may affect the results of the study, judged by the investigator.
• Specific history of allergies.

Laborértékek

• Abnormal QTc interval of electrocardiogram within the 6 months prior to screening.

Életkor

• Pregnant or lactating females; women of reproductive age who are not using effective contraception.

Egyéb

• The spleen is palpable at least 5 centimeters below the left costal margin upon palpation at baseline.
• Any non-PV myeloproliferative neoplasms (MPN).
• Hematological indicators do not meet the requirements at the time of screening.
• Individuals directly associated with the research and/or their immediate family members.
• Other factors which may potentially affect the assessment of the study results by the investigator.

• Male and female patients aged 18 years or older at the time of screening.
• A confirmed diagnosis of PV according to the revised 2016 World Health Organization criteria and are resistant to or intolerant of hydroxyurea or Interferon alpha.
• Have a treatment history for PV with resistance or intolerance to hydroxyurea or Interferon alpha.
• Subjects receiving hydroxyurea, Interferon alpha, or ruxolitinib must complete a washout period before administration of the investigational drug.
• Must agree to adhere to appropriate contraception requirements during the study period.
• All female subjects with fertility capacity tested negative for blood pregnancy.
• Voluntarily participate in clinical trials and agrees to participate in the study by giving written informed consent.